Cirrhotic portal hypertension
Conditions
Interventions
Conventional dose group:Alverine 60mg/tid
High dose group:Alverine 120mg/tid
Sponsors
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years, no gender limit; 2. Patients with cirrhosis confirmed by clinical, laboratory, imaging and/or liver biopsy; 3. Hepatic venous pressure gradient (HVPG) >= 10 mmHg; 4. Be willing to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have taken carvedilol, propranolol and other non-selective beta-blockers in the last 4 weeks; 2. Patients with dominant hepatic encephalopathy, esophageal varices rupture and bleeding in the last 4 weeks; 3. Previous transjugular intrahepatic portal shunt (TIPS); 4. Patients with a history of alcoholism within the past 12 weeks and who could not stop drinking during the study period (equivalent to alcohol dose >=40g/ day for men and >=20g/ day for women); 5. Patients with severe jaundice (serum Tbil level >=85µmol/L) or obvious renal insufficiency (serum Cr>=1.2ULN); 6. Severe electrolyte abnormalities (Blood sodium < 125 mmol/L) or life-threatening leukopenia (WBC < 1x10^9/L); 7. Patients with poorly controlled hypertension, diabetes or other serious heart and lung diseases; 8. Patients with confirmed or suspected malignant tumor; 9. Patients who have undergone splenectomy; 10. Patients infected with HIV; 11. Known allergy to alverine; 12. Patients who have taken tricyclic antidepressants and similar drugs, procainamine or derivatives, H1 antihistamines, and systemic cholinergic drugs within the last 4 weeks; 13. Pregnant and lactating patients or patients whose pregnancy is not ruled out; 14. Participants in other drug trials within 12 weeks; 15. Participation was not considered appropriate by other researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatic venous pressure gradient (HVPG); | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver decompensated events;Variceal bleeding;Ascites;Hepatic encephalopahty;Vital signs;Adverse event;Serious adverse event;Laboratory tests;Liver biopsy; | — |
Countries
China
Contacts
Public ContactZhang Chunqing, Xie Weifen
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Outcome results
None listed